JERSEY CITY, N.J., Nov. 10, 2021 (GLOBE NEWSWIRE) — SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today reported financial results for the third quarter ended on September 30, 2021 and provided an update on recent clinical and corporate developments.
“We are rapidly advancing every element of the BREXAFEMME commercial launch according to plan, and our efforts have been paying off,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “Physician and payer receptivity to the BREXAFEMME value proposition is extremely encouraging as we continue to see an impressive upward trajectory of prescriptions and expanded coverage during the initial stages of the launch. We also look forward to reporting top-line data from our Phase 3 CANDLE study by early Q2 of next year. Furthermore, we are thrilled to announce the successful completion of the Phase 1 study of our new IV formulation of ibrexafungerp which will enable us to further expand the potential range of indications in the hospital setting.”
BREXAFEMME Commercial Update
Ibrexafungerp Clinical Updates
Ibrexafungerp Scientific Presentations and Publications
Corporate Developments
Third Quarter 2021 Financial Results
BREXAFEMME generated a total of $0.5 million in net product revenues between the first week of August and September 30, 2021, which is in line with internal expectations.
Cost of product revenues was $0.1 million for the three months ended September 30, 2021 compared to $0.0 million for the three months ended September 30, 2020.
Research and development expense for the three months ended September 30, 2021 decreased to $4.4 million from $8.0 million for the three months ended September 30, 2020. The decrease of $3.6 million, or 45%, for the three months ended September 30, 2021, was primarily driven by a decrease of $1.6 million in chemistry, manufacturing, and controls (CMC) expense, a decrease of $1.2 million in clinical development expense, a decrease of $0.6 million in regulatory expense, and a net decrease in other research and development expense of $0.2 million.
Selling, general & administrative expense for the three months ended September 30, 2021 increased to $15.4 million from $3.5 million for the three months ended September 30, 2020. The increase of $11.9 million, or 341%, for the three months ended September 30, 2021, was primarily driven by a $8.7 million increase in commercial related expense associated with the ongoing commercialization of BREXAFEMME, an increase of $1.3 million in salary related costs, an increase of $0.7 million in expense associated with increased information technology costs, an increase of $0.7 million in medical affairs expense, and a net increase of $0.5 million in other selling, general and administrative expense.
Total other income was $18.8 million for the three months ended September 30, 2021, compared to total other income of $12.4 million for the three months ended September 30, 2020. During the three months ended September 30, 2021 and 2020, SCYNEXIS recognized non-cash gains of $18.8 million and $7.8 million, respectively, on the fair value adjustment of the warrant liabilities and during the three months ended September 30, 2021, and 2020, recognized non-cash gains of $1.4 million and $5.3 million on the fair value adjustment of the derivative liabilities, respectively.
Net loss for the three months ended September 30, 2021, was $0.6 million, or ($0.02) net loss per basic and ($0.06) net loss per diluted share, compared to net income of $0.9 million, or $0.09 net income per basic and ($0.28) net loss per diluted share for the three months ended September 30, 2020.
Cash and cash equivalents totaled $100.1 million on September 30, 2021, compared to $93.0 million in cash and cash equivalents on December 31, 2020. Based upon its existing operating plan, the company believes that its existing cash and cash equivalents, the sale of a portion of its New Jersey NOLs, and the anticipated sales of BREXAFEMME will enable SCYNEXIS to fund its operating requirements into 2023.
About Ibrexafungerp
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains.The New Drug Application (NDA) for BREXAFEMME® (ibrexafungerp tablets) was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. FDA also granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia) and invasive aspergillosis (IA), and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.
About SCYNEXIS
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS scientists are developing the company’s lead asset, ibrexafungerp (formerly known as SCY-078), as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. SCYNEXIS has initiated the launch of its first commercial product in the U.S., BREXAFEMME® (ibrexafungerp tablets). The U.S. Food and Drug Administration (FDA) approved BREXAFEMME on June 1, 2021. In addition, late-stage clinical investigation of ibrexafungerp for the prevention of recurrent Vulvovaginal Candidiasis (VVC) and the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visit www.scynexis.com.
Forward-Looking Statements
Statements contained in this press release regarding expected future events or results are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: SCYNEXIS has a projected cash runway into 2023, its expectations to report top-line data from its Phase 3 CANDLE study by early Q2 of next year, the new IV formulation of ibrexafungerp will enable the company to further expand the potential range of indications for ibrexafungerp in the hospital setting, its expectation to have the Phase 3 CANDLE study last-patient/last-visit by the end of 2021 with top-line results by early Q2 2022 and a supplemental NDA submission is anticipated in Q2 2022 with a potential approval in late 2022, enrollment in the Phase 2 SCYNERGIA study is expected to accelerate over the next two quarters and top-line results are anticipated in the second half of 2022. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited, to: BREXAFEMME may not be accepted by physicians and patients at the rate SCYNEXIS expects; risks inherent in SCYNEXIS’ ability to successfully develop and obtain FDA approval for ibrexafungerp for additional indications, including the IV formulation of ibrexafungerp currently in Phase 1; unexpected delays may occur in the timing of acceptance by the FDA of an NDA submission; the expected costs of studies and when they might begin or be concluded; SCYNEXIS’ need for additional capital resources; and SCYNEXIS’ reliance on third parties to conduct SCYNEXIS’ clinical studies and commercialize its products. These and other risks are described more fully in SCYNEXIS’ filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, including in each case under the caption “Risk Factors,” and in other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CONTACT:
Investor Relations
Irina Koffler
LifeSci Advisors
Tel: (646) 970-4681
ikoffler@lifesciadvisors.com
Media Relations
Gloria Gasaatura
LifeSci Communications
Tel: (646) 970-4688
ggasaatura@lifescicomms.com
SCYNEXIS, INC. | ||||||||||
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||
(in thousands, except share and per share data) | ||||||||||
Three Months Ended September 30, | ||||||||||
2021 | 2020 | |||||||||
Revenue: | ||||||||||
Product revenue, net | $ | 516 | $ | − | ||||||
License agreement revenue | − | − | ||||||||
Total revenue | 516 | − | ||||||||
Operating expenses: | ||||||||||
Cost of product revenue | 145 | − | ||||||||
Research and development | 4,401 | 8,030 | ||||||||
Selling, general and administrative | 15,411 | 3,481 | ||||||||
Total operating expenses | 19,957 | 11,511 | ||||||||
Loss from operations: | (19,441 | ) | (11,511 | ) | ||||||
Other expense (income): | ||||||||||
Amortization of debt issuance costs and discount | 413 | 311 | ||||||||
Interest income | (8 | ) | (5 | ) | ||||||
Interest expense | 1,019 | 330 | ||||||||
Other expense | − | 20 | ||||||||
Warrant liabilities fair value adjustment | (18,810 | ) | (7,786 | ) | ||||||
Derivative liabilities fair value adjustment | (1,400 | ) | (5,290 | ) | ||||||
Total other income | (18,786 | ) | (12,420 | ) | ||||||
(Loss) income before taxes | (655 | ) | 909 | |||||||
Income tax benefit | (50 | ) | − | |||||||
Net (loss) income | $ | (605 | ) | $ | 909 | |||||
Net (loss) income per share attributable to common stockholders – basic | ||||||||||
Net (loss) income per share – basic | $ | (0.02 | ) | $ | 0.09 | |||||
Net loss per share attributable to common stockholders – diluted | ||||||||||
Net loss per share – diluted | $ | (0.06 | ) | $ | (0.28 | ) | ||||
Weighted average common shares outstanding – basic and diluted | ||||||||||
Basic | 26,616,628 | 10,627,618 | ||||||||
Diluted | 27,754,828 | 13,389,014 |
SCYNEXIS, INC. | ||||||||
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(in thousands) | ||||||||
September 30, 2021 | December 31, 2020 | |||||||
Cash and cash equivalents | $ | 100,109 | $ | 93,041 | ||||
Total current assets | 103,933 | 98,206 | ||||||
Operating lease right-of-use asset | 2,850 | 2,999 | ||||||
Total assets | 109,882 | 102,536 | ||||||
Warrant liabilities, current | 1,037 | 17,564 | ||||||
Total current liabilities | 13,220 | 26,396 | ||||||
Warrant liabilities, long term | 14,298 | 33,592 | ||||||
Convertible debt and derivative liability | 10,805 | 16,516 | ||||||
Loan payable | 28,579 | − | ||||||
Operating lease liability, long term | 3,267 | 3,274 | ||||||
Total liabilities | 72,268 | 79,778 | ||||||
Total stockholders’ equity | 37,614 | 22,758 | ||||||
Total liabilities and stockholders’ equity | $ | 109,882 | $ | 102,536 |
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